multicenter withdrawal clinical trials of n-acetyl glucosamine capsule for ibs-d treatment

Conditions: Irritable Bowel Syndrome

Summary: this study is a withdrawal randomized clinical trail to evaluate the clinical efficacy and safety of 1.1 chemical drugs n-acetyl glucosamine on chinese ibs-d patients coming from four centers in chongqing. 180 ibs-d patients in this research are accord with the rome iii diagnostic criteria, screening/import period pain intensity scores of the nrs week mean value are 3.0 plus and the days which at least more than one time a stool type are 6 or 7 type over 2 days/week. test cycle includes screening/import period (2 weeks), open treatment period (8 weeks), a double-blind placebo-controlled randomized withdrawal period (8 weeks), the main outcome measures are pain intensity (nrs score 11 point scale) and stool type ( bristol type). and secondary endpoints included overall symptoms sensory scores, defecation frequency, abdominal distension, mucous stool and quality of life parameters (ibs-36 scale). after the end of the treatment period, the participants whose pain intensity and stool type are effective subjects into a randomized withdrawal period, analysis and comparison of the difference between treatment group and placebo group withdrawal rate and curative effect index score reduces.


Eligibility criteria:
inclusion criteria: * man or woman, aged 18 to 65 years, inclusive. * based on the roman iii diagnostic criteria for diagnosis of ibs-d subjects, recurrent abdominal pain or discomfort (hard to describe the discomfort of pain), monthly attack within the past 3months at least 3 days. with two or more of the following three kinds of symptoms: at least a portion of the time abdominal pain or defecate increase when discomfort. at least a portion of the time abdominal pain or the row of loose stools when discomfort. at least a portion of the time abdominal pain or discomfort improved after defecation. symptoms for at least 6 months before diagnosis * screening/import period pain intensity scores of the nrs week mean value are 3.0 plus and the days which at least more than one time a stool type are 6 or 7 type over 2 days/week. * voluntarily signed the informed consent form exclusion criteria: * the absorption of any known adverse * history of gastrointestinal surgery ( not including appendectomy) * history of organic gastrointestinal diseases: ibs, cancer etc. * history of chronic diseases: anemia (hemoglobin\ 1.5 times, bun (blood urea nitrogen)\> 1.2 times, cr \> 1.0 times normal. * the disease of lactose intolerance, gallstones, endometriosis, easily confused with ibs symptoms of ; * progressive weight loss; * concomitant medication is unable to stop but affect the gastrointestinal movement and function in the experiment, such as antibiotic drugs, the drugs of regulating the intestinal microecology; * concomitant medication use continuously for more than a week but affect the gastrointestinal movement and function in the experiment, such as parasympathetic inhibitors, nondepolarizing agent, antidiarrheal, opioid formulation, etc; * other researchers think not suitable for the list;

Keywords: diarrhea abdominal pain